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Export Rights Under Section 107A: Alembic and the Bayer Dispute

A court permission to export a generic for research and regulatory purposes is an intangible with an unusually narrow boundary — and the boundary is the whole asset.

Published
Updated
Reading time
4 min
Questions
6 answered
  • High Complexity
Topic
IBC Insolvency
Published
September 7, 2026
Last updated
Sep 7, 2026
Reading time
4 min
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Last updated: September 2026Verified against: Government sources

The dispute

In March 2017, the Delhi High Court granted Indian pharma company Alembic the permission to export the generic version of German pharma giant Bayer's lifesaving medicines for regulatory and research purposes. The ruling comes as much needed relief to Indian drug manufacturers locked in legal battles with the inventors of such drugs.

The German company had taken the legal route in 2016 to stop Alembic from exporting the generic version of its blood thinner brand "Xarelto". In what is seen as a major setback for Bayer, the Indian court has allowed Alembic to export the generic version for clinical development and research purposes.

Alembic was required to give an undertaking that the drug wouldn't be exported for any purpose other than those listed in Section 107A of the Indian Patents Act, 1970. However, Bayer alleged that Alembic had exported 90kgs of the drug worth INR 3 Crores which was in violation of Section 107A of the Indian Patents Act, 1970.

Why export rights of this kind are defined by their limits

Most intangibles are described by what they permit. This one is defined by what it excludes.

Section 107A permits acts done for uses reasonably related to the development and submission of information required under law — the regulatory exception that lets a generic manufacturer prepare for market entry before a patent expires. The permission is real, and commercially significant: it removes years of delay after expiry.

But the undertaking is part of the asset. Alembic had to confirm the drug wouldn't be exported for any purpose other than those listed in Section 107A. Exports for commercial sale are not covered, and the allegation that 90kgs of the drug worth INR 3 Crores went beyond the exception is precisely a dispute about the boundary.

For a valuer, three consequences follow.

First, the benefit stream is not product revenue. The right generates no sales of the drug; it generates earlier market entry after expiry. The cash flows to model are the accelerated launch, not the exported quantities.

Second, control is contested. The right exists but is being litigated, so the probability that it survives in its present form is part of the valuation — a case for probability weighting rather than a point estimate.

Third, the economic life is short and defined by the patent. The exception matters only until expiry; after that, ordinary competition applies. This is a textbook case of legal factors setting a life far shorter than the commercial opportunity.

Where it sits in the framework

TestExport rights under section 107A
IdentifiabilityArises from a legal right — a statutory exception confirmed by court order
ControlHeld subject to an undertaking; contested in litigation
Future economic benefitsEarlier market entry on patent expiry, not revenue from the permitted exports
SeparabilityNone — the permission attaches to the party and its undertaking

Litigation as a purpose of valuation

The Standard lists among the purposes of an intangible valuation litigation, when there has been a breach of contract or right and the compensation has to be determined. This case is exactly that: if the exception was exceeded, the measure of Bayer's loss requires the patent right to be valued and the infringement quantified.

The consignment figure — 90kgs of the drug worth INR 3 Crores — is evidence of the scale in dispute, not of the value of either party's intangible.

What a valuer should do

  1. Model the acceleration benefit, not the exported volumes.
  2. Weight for the probability that the permission survives challenge.
  3. Cap the life at patent expiry in the relevant markets.
  4. State the undertaking and its scope as an assumption in the report.

Common mistakes valuing export rights

  • Valuing the permitted export volumes as commercial revenue.
  • Treating a contested right as unconditional.
  • Extending the life beyond the patent term the exception depends on.
  • Ignoring the undertaking that limits the permitted purposes.
Quick recapKey facts & short answers

Key Facts About Export Rights

  • Applies in: All states across India, under the relevant central law.
  • Mode: Mostly online via the official government portal.
  • Typical timeline: Ranges from a few days to a few weeks depending on the case.
  • Non-compliance: May attract penalties, interest or late fees.
  • Expert help: TaxClue completes the entire process end to end for you.

What did the court permit?

In March 2017, the Delhi High Court granted Indian pharma company Alembic the permission to export the generic version of German pharma giant Bayer's lifesaving medicines for regulatory and research purposes.

What had Bayer sought?

The German company had taken the legal route in 2016 to stop Alembic from exporting the generic version of its blood thinner brand Xarelto.

Read the notice the day it arrives; most of the damage is done by the weeks it sits unopened.

— TaxClue Compliance Desk

Export Rights: a key compliance topic in Indian tax and corporate law that businesses and individuals must understand to remain compliant.

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Vikas Sharma Tax & Compliance Expert at TaxClue

Experienced in company registration, GST, trademark, and compliance. Helping Indian businesses stay compliant.

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Disclaimer: This article is for general informational purposes only and does not constitute professional tax, legal or financial advice. Laws, rates and due dates change and can vary by individual case — always verify with the relevant government source (e.g. mca.gov.in, incometax.gov.in) or consult a qualified professional before acting. TaxClue accepts no liability for decisions taken based on this content.

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Short, direct answers to the 6 questions readers ask most on this topic.

In March 2017, the Delhi High Court granted Indian pharma company Alembic the permission to export the generic version of German pharma giant Bayer's lifesaving medicines for regulatory and research purposes.

The German company had taken the legal route in 2016 to stop Alembic from exporting the generic version of its blood thinner brand Xarelto.

In what is seen as a major setback for Bayer, the Indian court allowed Alembic to export the generic version for clinical development and research purposes.

Alembic was required to give an undertaking that the drug would not be exported for any purpose other than those listed in Section 107A of the Indian Patents Act, 1970.

Bayer alleged that Alembic had exported 90 kg of the drug worth INR 3 crore in violation of Section 107A of the Indian Patents Act, 1970.

The ruling came as much needed relief to Indian drug manufacturers locked in legal battles with the inventors of such drugs.